FDA.reportPublic FDA data

Application 089397

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOPYRROLATEGLYCOPYRROLATEInjectable; Injection0.2MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATELifestar Pharma LLC0f4a4b94-71e0-49ed-8f1e-c760e4dd31372026-03-25Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEMajor Pharmaceuticals6e5bfe6d-d321-4f0f-86e2-457d8fd10a6a2026-03-19Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
glycopyrrolateGLYCOPYRROLATEBionpharma Inc.512d3f1e-c35c-87c2-e063-6394a90a8de02026-03-05Warnings, Adverse reactionsName fallback
brand name: glycopyrrolate
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATENCS HealthCare of KY, LLC dba Vangard Labs5ed930b7-a36e-4bf8-b1d1-dad238d3dd182026-02-25Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack10ea264f-e157-4e13-9d79-b4228daf359d2026-02-17Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEFlorida Pharmaceutical Products, LLC2cda1ed5-10bb-4651-acbf-be44ad7096652026-02-12Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycateGLYCOPYRROLATEIntra-Sana Laboratories830ba1be-bef3-417c-a915-964cc6005b922026-01-13Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepackeaf38b98-006f-4f4e-bc1c-6fe381f44b362026-01-07Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepackb96c54a1-b8a5-4132-ae6d-725e0e5b91f42026-01-07Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
Glycopyrrolate Oral SolutionGLYCOPYRROLATEAJENAT PHARMACEUTICALS LLC7049feaf-004a-481f-b129-996b21c3170a2025-12-29Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEJvet Pharmaceuticals LLC4b335c67-4f8f-47e5-abfc-f8c2c15496d72025-12-19Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEAurolife Pharma LLC677f8495-a870-45b6-bb65-75b449f040ce2025-12-11Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEChartwell RX, LLC5773cf63-4006-4d8f-b53b-c84bcfe19e4a2025-12-10Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATERising Pharma Holdings, Inc.58c4cb1f-59b8-4be9-a222-2264ca077d932025-12-03Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
Glycopyrrolate Oral SolutionGLYCOPYRROLATEGranules Pharmaceuticals Inc.0f05c5d3-9c41-4dae-88d1-18cbddc694872025-12-02Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATESolco Healthcare US, LLC2972f22e-378c-450b-8869-1354a9bd0ffc2025-11-30Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATESolco Healthcare US, LLC3707f06a-6cba-4f5c-86ab-fb95bc2a933c2025-11-30Warnings, Adverse reactionsName fallback
brand name: GLYCOPYRROLATE
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution430635e8-7c9e-77f6-e063-6294a90a4c8a2025-11-07Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.83602e34-7a8c-4606-b43e-23ab909b6c1a2025-11-05Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.74d51ba3-0ca0-4a04-aa87-1c243f885bd82025-11-05Warnings, Adverse reactionsName fallback
brand name: Glycopyrrolate
generic name: GLYCOPYRROLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.